EliA SmDP Well — Class II medical device recall Z-0697-2016
Terminated recall by Phadia Ab, reported 2016-02-03, distributed nationwide. All equivocal and positive results (greater or equal 7 EliA U/ml) on EliA SmDP well lot 0018 may be incorrect
| Recall number | Z-0697-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Phadia Ab, Uppsala, N/A, Sweden |
| Recall initiated | 2015-12-28 |
| Classified | 2016-01-27 |
| Reported by FDA | 2016-02-03 |
| Terminated | 2016-08-16 |
| Distributed | Nationwide (US) |
| Quantity | 76 |
| Lot numbers | 0018 |
| Expiration dates | 2016-11-30 |
Product
EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA SmDP uses the EliA IgG method on the instruments Phadia 100 and Phadia 250.
Reason for recall
All equivocal and positive results (greater or equal 7 EliA U/ml) on EliA SmDP well lot 0018 may be incorrect and must be considered invalid. Patient samples in complaint investigations caused unspecific signals up to 22 U/ml on EliA SmDP well lot 0018. The nonspecific signals are not caused by anti-Sm antibodies, nor by streptavidin antibodies.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0697-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.